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Duvakitug to induce remission in moderate to severe ulcerative colitis

A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Induction Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis.

Phase 3 Interventional Sanofi · NCT07184996

This 12-week treatment will test whether duvakitug helps adults (and some older teens) with moderately to severely active ulcerative colitis get into remission and feel better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment980 (estimated)
Ages16 Years to 80 Years
SexAll
SponsorSanofi Industry-sponsored
Locations191 sites (Peoria, Arizona and 190 other locations)
Trial IDNCT07184996 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 induction program testing duvakitug in people with moderately to severely active ulcerative colitis. Participants may enter a 12-week pivotal induction (duvakitug or placebo), a single-arm open-label feeder induction, and a 12-week extended induction for non-responders, with total participation lasting up to 35 weeks including screening and follow-up. Efficacy and safety will be measured by clinical response and adverse event monitoring across multiple international sites, with Sanofi as the lead sponsor and Teva as a collaborator. Participants who respond may be eligible to continue into a maintenance study, while others will complete a 45-day follow-up.

Who should consider this trial

Good fit: Adults aged 18–80 (and some 16–17 year olds where allowed) with a confirmed history of moderately to severely active ulcerative colitis for at least 3 months who have had an inadequate response, loss of response, or intolerance to conventional or advanced therapies are the intended candidates.

Not a fit: Patients with Crohn's disease, indeterminate colitis, ulcerative proctitis, recent major bowel surgery, prior high-grade GI dysplasia, prior anti-TL1A investigational therapy exposure, unstable background treatments, or those taking prohibited medications are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, duvakitug could help more patients achieve clinical remission and reduce symptoms, providing a new option for those who have not benefited from existing therapies.

How similar studies have performed: Early-phase work on anti‑TL1A approaches has shown promising signals, but definitive benefit and safety must be confirmed in Phase 3 randomized trials like this one.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to \<18 years of age who meet the definition of Tanner Stage 5 for development
* Confirmed diagnosis of moderately to severely active UC for at least 3 months prior to Baseline
* Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies

Exclusion Criteria:

* Participants with Crohn's Disease (CD), indeterminate colitis
* Current diagnosis of Ulcerative Proctitis
* Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of \>3 bowel resections
* Prior or current high-grade gastrointestinal (GI) dysplasia
* Participants on treatment with but not on stable doses of conventional therapies prior to baseline
* Participants with prohibited medications or therapies prior to baseline
* Participants with previous exposure to anti-TL1A investigational therapy The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where this trial is running

Peoria, Arizona and 190 other locations

+141 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ulcerative Colitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.